{"id":423352,"date":"2024-10-20T06:46:02","date_gmt":"2024-10-20T06:46:02","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-183622016a12022\/"},"modified":"2024-10-26T12:41:51","modified_gmt":"2024-10-26T12:41:51","slug":"bs-iso-183622016a12022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-183622016a12022\/","title":{"rendered":"BS ISO 18362:2016+A1:2022"},"content":{"rendered":"

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
5<\/td>\nForeword <\/td>\n<\/tr>\n
6<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
10<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
13<\/td>\n4 \uea01General
5 Process definition
5.1 General <\/td>\n<\/tr>\n
14<\/td>\n5.2 Risk management
5.2.1 General considerations <\/td>\n<\/tr>\n
15<\/td>\n5.2.2 Cell-based starting material risk assessment
5.2.3 CBHP process risk assessment <\/td>\n<\/tr>\n
16<\/td>\n6 Manufacturing environment
6.1 General
6.2 Alternative processes <\/td>\n<\/tr>\n
17<\/td>\n6.3 Manufacturing environment design
6.3.1 Containment area
6.3.2 Construction containment features
6.4 Layout
6.5 Material and personnel flow
6.5.1 General <\/td>\n<\/tr>\n
18<\/td>\n6.5.2 Equipment
6.5.3 Handling of waste material
6.6 HVAC system
6.7 Utility services and ancillary equipment
6.8 Environmental and personnel monitoring programmes
7 Equipment
7.1 General <\/td>\n<\/tr>\n
19<\/td>\n7.2 Additional requirements
8 Personnel
8.1 General
8.2 Personnel procedures
8.3 Gowning procedures
8.4 General employee health <\/td>\n<\/tr>\n
20<\/td>\n9 Manufacture of product
9.1 General
9.2 Control of starting material
9.2.1 Cell-based starting material
9.2.2 Other starting materials <\/td>\n<\/tr>\n
21<\/td>\n9.3 Manufacturing procedures
9.4 In-process controls and process monitoring
9.5 Virus elimination and inactivation
10 Process simulation and process confirmation
10.1 General <\/td>\n<\/tr>\n
22<\/td>\n10.2 Process simulation
10.3 Process confirmation studies
10.4 Media selection and growth support <\/td>\n<\/tr>\n
23<\/td>\n11 Finished product release: test for sterility
11.1 General
11.2 Additional requirements <\/td>\n<\/tr>\n
24<\/td>\n12 Finished product release: testing for biological contamination that cannot be detected by the test for sterility
12.1 General
12.2 Extrinsic biological contamination
12.3 Intrinsic biological contamination <\/td>\n<\/tr>\n
25<\/td>\nAnnex A (informative) Examples of microbial risks for CBHP <\/td>\n<\/tr>\n
26<\/td>\nAnnex B (normative) Decision trees for application of risk assessment for cell-based starting materials <\/td>\n<\/tr>\n
28<\/td>\nAnnex C (informative) Containment facilities <\/td>\n<\/tr>\n
35<\/td>\nAnnex D (normative) CBHP starting material <\/td>\n<\/tr>\n
37<\/td>\nAnnex E (normative) Containment requirements for procured, non-sterile starting materials before entering the manufacturing area <\/td>\n<\/tr>\n
38<\/td>\nAnnex F (informative) Typical elements of a process definition <\/td>\n<\/tr>\n
39<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Manufacture of cell-based health care products. Control of microbial risks during processing<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2023<\/td>\n42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":423360,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-423352","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/423352","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/423360"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=423352"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=423352"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=423352"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}